Prospective Multicentre Non-interventional Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer

Prospective, Multicentre, Non-interventional (Observational) Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01574846

Acronym

Vantas

Enrollment

142

Registered

2012-04-10

Start date

2011-01-31

Completion date

2014-04-30

Last updated

2014-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

The aim of this non-interventional (observational) study is to document, in collaboration with established urologists in Scandinavia, experience gained from routine use of Vantas® for the treatment of patients with advanced prostate cancer. In this observational study particular attention will be directed to treatment duration, quality of life and patient and physician acceptance of the medicinal product for long-term therapy. Patient-based measurement parameters such as quality of life and degree of satisfaction will allow registration of information that extends beyond the clinical parameters. The knowledge gathered will enable patient acceptance of long-term therapy to be evaluated. Clinical outcome will also be documented by measuring serum testosterone and prostate specific antigen (PSA) levels.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male patients for whom hormone treatment for advanced prostate cancer is indicated * Age \> 18 years. * Documented elevated PSA levels.

Exclusion criteria

Contraindications for Vantas® (in accordance with Summary of Product Characteristics (SmPC))

Design outcomes

Primary

Measure	Time frame
Treatment duration follow-up for each patient.	1 year

Secondary

Measure	Time frame	Description
Blood samples	1 year	PSA and Testosterone measurement
Quality of Life measurements	1 year	EORTC documents

Countries

Sweden

Outcome results